Vaccine safety

Safe injectionUNICEF procured over 710 million immunization syringes in 2013

In 1999, with the goal of preventing the transfer of blood-borne diseases such as HIV/AIDS and hepatitis B and C, the World Health Organisation (WHO), UNICEF and the United Nations Population Fund (UNFPA) developed a policy on Injection Safety. The policy was designed to sensitise the market to a shift toward safer injection devices with the goal of phasing out the use of non-AD syringes and syringe sterilisation by 2003. At the time, there was almost a monopoly situation in the AD syringe market, with prices several times higher than regular disposable syringes. It took a decade of market influencing efforts to reach, by 2009, a healthier supplier base, with prices falling below five US cents per unit for the first time.

UNICEF communicated its goal to achieve a more balanced market to several stakeholders, encouraging smaller suppliers to increase their production capacity to obtain economy of scale, while at the same time not guaranteeing that UNICEF would buy their products. The 2011 tender exercise has resulted in UNICEF awarding long term arrangements to four suppliers.

Enhancing injection safetyUNICEF signalled to industry in the 2005 AD syringe tender, its objective to reduce the risk of reuse by stating that UNICEF has a preference for Auto-Disable Syringes with activation of the auto-disabling feature commencing prior to delivery of the fixed full dose.

In 2008, UNICEF started phasing out regular disposable reconstitution syringes and replacing them with either WHO prequalified re-use prevention (RUP) syringes or WHO pre-qualified sharps injury prevention featured syringes (SIP). The syringes are used for vaccine reconstitution. RUP and SIP syringes are offered as an option to countries and UNICEF is actively working with partners to phase in these types of syringes through the measles partnership.

Another safety feature advocated by UNICEF is the vaccine vial monitor (VVM). The VVM is a strip on each vial which colour to record the extremes of temperature it has been subjected to in transit. This allows recipients to check that the quality of the vaccine has not suffered due to exposure to extreme temperatures, and helps ensure that children are immunized with potent vaccines.

UNICEF has introduced Vaccine Arrival Reports (VARs) to ensure the safety and quality of vaccines. Each vaccine shipment is inspected upon arrival to ensure that the vaccines arrived in good condition, that they were not exposed to extreme temperatures and that they meet all the procurement specifications. This initiative is fundamental to monitoring the cold chain. The VAR return rate was 80 per cent in 2012. Because of the increased monitoring and inspection resulting from the VARs, there has been an improvement in the quality of vaccines delivered to countries.

UNICEF suppliers have started using Electronic Time Temperature Monitoring Devices (ETTMDs) for international vaccine shipments following WHO recommendations. The new devices serve as a quick reference to help recipient countries determine whether the shipment – or parts of the shipment – have been exposed to temperatures at which vaccines could have been damaged; and help the procurement agency determine when, where, and to what extent temperature limits have been exceeded.